Efficacy of Cardioviva™ Probiotic Yogurt Formulation

Hypercholesterolemia Clinical Trial

Official title:

Efficacy of a Microencapsulated Probiotic Yogurt Formulation as a Health Promoting Agent

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01185795
• Other study ID #: MP-001
• Status: Completed
• Phase: Phase 2
• First received: August 18, 2010
• Last updated: June 29, 2012
• Start date: September 2008
• Est. completion date: April 2009

Study information

• Verified date: June 2012
• Source: Micropharma Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Background: Several studies have reported limited or no reduction in serum lipid concentrations in response to probiotic formulations. More recently, probiotics have shown promise in treating metabolic disease, due to improved strain selection and delivery technologies.

Objective: To evaluate the lipid lowering efficacy of a yogurt formulation containing microencapsulated Bile Salt Hydrolase (BSH)-active Lactobacillus reuteri cardioviva, taken twice per day over 6 weeks, in subjects with hypercholesterolemia.

Design: This is a double-blinded, multi-centric, placebo-controlled, randomized, parallel-arm study. The study will last a total of 10 weeks including 2-week wash-out, 2-week run-in, and 6- week treatment period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 74 Years

Eligibility

Inclusion Criteria:

• Healthy males and females.

• Aged 18-74 years old.

• Low Density Lipoprotein (LDL-C) above 3.4 mmol/L (<15% variation between visits V1 and V2-1).

• Triglyceride (TG) levels below 4.0 mmol/l (check at V0 and V2-1).

• Body Mass Index (BMI) range was 22 to 32 kg/m2.

• Ability to understand dietary procedures.

• Judged by the investigators as compliant (>80%) with product consumption (check at V2-1), and motivated.

• Signed informed consent form prior to inclusion in the study

• Note: Subjects were permitted to take stable doses of thyroid hormone, anti-hypertensive agents, and contraceptive hormones (e.g. contraceptive pills or patches), as long as these were continued equivalently throughout the duration of study.

Exclusion Criteria:

• Use of statin or other cholesterol lowering prescription drugs within the last 6 months.

• Use of plant sterols, omega-3, fish oil, soy protein, soluble oat fiber, psyllium seed husk, or other cholesterol lowering non-prescription supplements within last 3 months.

• History of chronic use of alcohol (>2 drinks/day).

• Use of systemic antibodies, corticosteroids, androgens, or phenytoin.

• Myocardial infarction, coronary artery bypass, or other major surgical procedures within the last six months.

• Lactose intolerance or allergies to dairy products.

• History of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, diabetes, gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer (evidence of active lesions, chemotherapy or surgery in the past year).

• Chronic user of probiotics or fiber laxative (greater than 2 doses/week), or stimulant laxatives.

• History of eating disorders.

• Exercise greater than 15 miles/week or 4,000 kcal/week.

• Pregnancy, breast feeding, or intent to get pregnant.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• Cardioviva™ yogurt
L. reuteri cardioviva in yogurt, twice per day (BID), 6 weeks
• Placebo yogurt
yogurt, twice per day (BID), 6 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Micropharma Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome variable will be the percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C)		6 weeks	No